Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism

Completed

• Conditions: Pulmonary Embolism

• Registration Number: NCT00880737
• Lead Sponsor: Carlos III Health Institute

Brief Summary

The objectives of the PROTECT study are:

* To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).

* To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

* To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

* To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

* To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-13
• Study First Posted: 2009-04-14
• Status Verified: 2010-02
• Primary Completion: 2011-06
• Last Update Submitted: 2011-06-14
• Last Update Posted: 2011-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

• Acute symptomatic Pulmonary Embolism (PE) confirmed by:

  • CT pulmonary angiography positive for PE
  • Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)
  • V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.

Exclusion Criteria

• Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min).
• Informed consent not obtained.
• Pregnancy.
• Life expectancy of less than 3 months.
• Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.
• Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.
• Participation in another clinical trial for treatment of PE.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome considered will be death by any cause in the month following diagnosis.	30 days after PE diagnosis

Trial Locations

Locations (1)

Ramón y Cajal Hospital; 🇪🇸 Madrid, Spain